(93 days)
This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.
Trending Option is a software and hardware modification to the Adult Star Ventilator (K872466). It adds three features: 72 hour trending of ventilator and patient monitored parameters, storage of Patient Data, and Save and Recall of real time waveforms. This option requires both software and hardware upgrades. The software, or firmware, is retained in EPROM's. The hardware upgrade consists of a print circuit board with battery backed up 256K RAM. A label is added to the front of the ventilator indicating that this option has been installed. This option is designed to function with all available options for the Adult Star Ventilator.
Although the provided text describes a medical device, the "Trending Option for the Infrasonics Adult Star Ventilator," it does not contain information related to acceptance criteria for diagnostic performance. The 510(k) summary focuses entirely on hardware and software modifications, intended use, similarities to predicate devices, and environmental and system-level functional testing.
Therefore, the following information, typically found when describing the acceptance criteria and a study proving device performance (especially for AI/diagnostic devices), cannot be extracted from this document, as it doesn't pertain to diagnostic performance:
- A table of acceptance criteria and the reported device performance: No performance criteria (e.g., sensitivity, specificity, accuracy) are mentioned, nor are any performance results. The "results" column in the environmental tests simply states "Passed" for each test.
- Sample size used for the test set and the data provenance: No test set related to diagnostic performance is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to diagnostic performance is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there is no diagnostic performance test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a trending display, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for diagnostic performance is mentioned.
- The sample size for the training set: No training set is mentioned as this is a software/hardware upgrade for data display, not an AI model requiring training.
- How the ground truth for the training set was established: Not applicable.
Summary of Testing (as provided in the document - focused on functionality and environmental robustness):
The "Summary of Testing" section is focused on demonstrating the functional robustness and safety of the Trending Option within the Adult Star Ventilator system, not its diagnostic or clinical performance.
Environmental Tests:
These tests ensure the device can operate reliably under various environmental conditions.
| Test Description | Results |
|---|---|
| Powerline Conducted Emissions | Passed |
| Radiated Emission Measurements | Passed |
| Radiated E-Field Susceptibility | Passed |
| Electrostatic Discharge Susceptibility | Passed |
| AC Voltage Fluctuation | Passed |
| AC Voltage Dropout | Passed |
| Slow Sag and Surges | Passed |
| Fast Transient Burst | Passed |
| Fast Surges | Passed |
| Magnetic Fields Emissions | Passed |
| Conducted Electromagnetic Energy | Passed |
| Magnetic Field Immunity | Passed |
| Quasi-Static Electromagnetic Field | Passed |
| Sinusoidal Vibration | Passed |
| Random Vibration | Passed |
| Shock | Passed |
| High temperature | Passed |
| Low Temperature | Passed |
| Humidity | Passed |
System Level Tests:
These tests validate the correct implementation of the design and its compatibility with other ventilator options.
| Test | Description |
|---|---|
| Design Validation for the Trending Option | Validates that the Design and Performance Specification has been correctly implemented. (Implicit Acceptance Criteria: Meets all Design and Performance Specifications) |
| Design Validation of Options Selection | Verifies that all available options for the Adult Star can be correctly selected. (Implicit Acceptance Criteria: All options can be correctly selected without interference) |
| Generic Testing | A regression level to verify that function of the basic ventilator and available options still perform as required with the Trending Option Installed. (Implicit Acceptance Criteria: Basic ventilator and other options perform as required post-installation) |
Study Description (as inferred from the document):
The "study" described is a series of engineering and system integration tests to ensure the new "Trending Option" hardware and software upgrade for the Infrasonics Adult Star Ventilator functions correctly, is environmentally robust, and does not negatively impact the performance of the core ventilator or its existing options.
- Test Sets: The "test sets" for these studies would be the specific hardware and software configurations of the ventilator subjected to the environmental and system-level tests. No specific "sample size" in terms of patient data or cases is mentioned because the device is not performing a diagnostic task.
- Data Provenance: Not applicable in the context of diagnostic performance. The "data" being tested is the device's functional integrity.
- Ground Truth: For functional tests, the "ground truth" is that the device should operate according to its design specifications without failure. For environmental tests, the "ground truth" is that it should withstand specified conditions without malfunction. This is established by engineering standards and design requirements rather than clinical experts.
- Training Set: Not applicable as this is not a machine learning or AI-based diagnostic device.
{0}------------------------------------------------
510(k) Summary
Submitter's Name: Nellcor Puritan Bennett Inc.
- Address: 4280 Hacienda Drive Pleasanton, CA 94588
- (619) 450-9898 Phone:
- Contact Name: Albert Paul
- Date of Summary: October 31, 1996
- Trade Name: Trending Option for the Infrasonics Adult Star Ventilator
- Common Name: Adult Ventilator
- Continuous Ventilator (21 CFR 868.5895) Classification: Class II
- Predicate Device: Puritan Bennett Graphics 2.0 option for the Puritan-Bennett 7200 ae ventilator Bird Products Corp. Graphic Monitor
Trending Option is a software and hardware Description of Device: modification to the Adult Star Ventilator (K872466). It adds three features: 72 hour trending of ventilator and patient monitored parameters, storage of Patient Data, and Save and Recall of real time waveforms. This option requires both software and hardware upgrades. The software, or firmware, is retained in EPROM's. The hardware upgrade consists of a print circuit board with battery backed up 256K RAM. A label is added to the front of the ventilator indicating that this option has been installed. This option is designed to function with all available options for the Adult Star Ventilator.
Intended Use: This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician
A5
{1}------------------------------------------------
identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.
Statement of Similarities and/or Differences With Marketed Devices:
The Infrasonics Trending option is a software and hardware upgrade to the Infrasonics Adult Star ventilator. The graphical display of trended parameters are shown on the existing Adult Star CRT. The Trending option is similar to the Puritan Bennett Graphics 2.0 option and the Bird Products Graphics Monitor. The Puritan Bennett Graphics 2.0 option requires a 7200 ae ventilator and an optional 7202 Display. The Bird Graphics monitor is an optional display for the Bird infant and adult ventilators. The Puritan Bennett and the Bird Graphics monitor acquire and display data in a similar manner as the Infrasonics Trending option. All designs use the same general principles and incorporate similar technologies, materials, energy sources, and components.
The primary function of all three products is to acquire ventilator data through an electronic means and store that data for later retrieval. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. It is concluded that the Trending Option is substantially equivalent to the Puritan-Bennett and Bird products.
Functionality with Available Options
The Trending Option for the Adult Star Ventilator is to be used in conjunction with or without other available options. The following is a list of the options and the 510(k) number associated with them:
| Product or Option to the Adult Star | Model Number |
|---|---|
| Adult Star Ventilator | K872466 |
| Pressure Control | K911804 |
| Flow Triggering | K954724 |
| Remote Alarm | K943106 |
| Lung Mechanics | K905272 |
| Pediatric and Compliance Compensations | K922654 |
It is possible, for example, for a ventilator to be configured with Trending and Pressure Control, or Trending, Pressure Control, and Flow Triggering. System testing was conducted to show the There is no limitation on the combinations that are available. The Trending option is independent of the other options.
A6
{2}------------------------------------------------
Summary of Testing:
The following environmental test were conducted on the Adult Star Ventilator with the Trending Hardware installed.
| Test Description | Results |
|---|---|
| Powerline Conducted Emissions | Passed |
| Radiated Emission Measurements | Passed |
| Radiated E-Field Susceptibility | Passed |
| Electrostatic Discharge Susceptibility | Passed |
| AC Voltage Fluctuation | Passed |
| AC Voltage Dropout | Passed |
| Slow Sag and Surges | Passed |
| Fast Transient Burst | Passed |
| Fast Surges | Passed |
| Magnetic Fields Emissions | Passed |
| Conducted Electromagnetic Energy | Passed |
| Magnetic Field Immunity | Passed |
| Quasi-Static Electromagnetic Field | Passed |
| Sinusoidal Vibration | Passed |
| Random Vibration | Passed |
| Shock | Passed |
| High temperature | Passed |
| Low Temperature | Passed |
| Humidity | Passed |
System Level Tests
The following system level tests were performed to validation the design of this option: . •
| Test | Description |
|---|---|
| Design Validation for the Trending Option | Validates that the Design andPerformance Specification has beencorrectly implemented. |
| Design Validation of Options Selection | Verifies that all available options forthe Adult Star can be correctlyselected. |
| Generic Testing (Includes specifictesting for all available options: | A regression level to verify thatfunction of the basic ventilator andavailable options still perform asrequired with the Trending OptionInstalled. |
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).